Kothari 2000.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
|
Participants |
Baseline characteristics Ondansetron
Dimenhydrinate
Included criteria: ASA I to III, undergoing elective laparoscopic cholecystectomy Excluded criteria: NA Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of motion sickness): no; (history of PONV, non‐smoker, perioperative opioids): unclear |
|
Interventions |
Intervention characteristics Ondansetron
Dimenhydrinate
|
|
Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Subjects with any AE (0 to 24 hours)
Headache (0 to 24 hours)
Sedation/drowsiness (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
|
Identification |
Sponsorship source: NA Country: USA Setting: inpatient, single‐centre Author's name: W.C. Boyd Institution: Departments of Surgery and Anesthesiology, Gundersen Lutheran, La Crosse, WI 54601, USA Email: AN Address: Departments of Surgery and Anesthesiology, Gundersen Lutheran, 1836 South Avenue, La Crosse, WI 54601, USA Duration of study: 1 November 1998 to 1 June 1999 Language: English Study's primary outcome: NA Trial registry number: NA |
|
Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Judgement comment: quote: "randomization was performed using a computer‐generated randomized list'' |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: insufficient information on blinding ("double‐blind") |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: quote: "nurses blinded to which antiemetic the patients had received recorded all episodes of nausea, vomiting, and retching in the recovery room by direct questioning, spontaneous complaint of the patient, or side effects'' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: quote: "of the 20 patient excluded, 15 had received an additional antiemetic preoperatively 4 were converted to open cholecystectomy, and the case of 1 was aborted because of the intraoperative finding of carcinomatosis. Of the 108 remaining patients available for analysis, 50 [of] whom were randomized to receive ondansetron (group 1) and 58 to receive dimenhydrinate (group 2)'' |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Judgement comment: quote: "patient demographics were similar in both treatment groups" Baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of motion sickness): no; (history of PONV, non‐smoker, perioperative opioids): unclear |